Viewing 1 - 10 of 73 jobs
in PCR(Promotional Copy Review) process Serve as the key Regulatory contact for PCR Provide primary regulatory review ... Requirements BA/BS and a minimum of 6-8 years in the pharmaceutical industry, advanced degree...
Position Summary: The Associate Director / Director, Post-Marketing Regulatory Affairs ensures OPDP compliance for all ... reimbursement programs, and others Supervise preparation of Regulatory reports including: Annual NDA/BLA, OPDP,...
ensure readiness for regulatory inspections from applicable Regulatory Authorities Leads the process of developing ... the review of Regulatory surveillance and the development of initiatives to drive adherence to compliance...
projects as assigned by the Director/VP, Regulatory Affairs. Maintain up-to-date knowledge of laws, regulations ... appropriate by Director, PRB. Provide regulatory review of draft promotional materials (pre-PRB). Regulatory PRB...
Manager/Associate Director,Regulatory Affairs - Promotional Review Job Description PURPOSE: Manage the Regulatory revie ... projects as assigned by the Director/VP, Regulatory Affairs. Maintain up-to-date knowledge of laws, regulations...
At least five years of experience in CMC regulatory affairs and quality assurance, preferably with peptide drug ... of FDA and ICH guidelines and familiarity with worldwide regulatory requirements pertaining to peptide development is...
multiple projects ranging in responsibility across the regulatory affairs department. 4) Supervise regulatory ... Regulatory in meetings and interacting with members of all development project teams to convey regulatory...
of Companies, is recruiting for an Associate Director, Regulatory Affairs - CMC, located in Raritan or Titusville, ... reproductive medicine. The Associate Director, Regulatory Affairs - CMC will contribute to the development of global...
not limited to, the following: - Manage regulatory aspects of Post-Marketing regulatory submissions and communications ... at least 3 years experience in post-marketing regulatory affairs, specifically pharmaceutical promotional activity. -...
req ID: 5544BR Job Title: Associate Director, Regulatory Affairs Functional Area: Research & ... The Associate Director, Regulatory Affairs will liaise with the review branches of FDA throughout the review process of...